The Celution(R) 700 System from Cytori Therapeutics, San Diego, Calif, will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act.
The company announced that the determination allows it to compile and submit a marketing application to the US Food and Drug Administration for the Celution(R) 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.
"This important decision provides greater clarity of our regulatory path in the U.S. and is consistent with our interpretation of current device regulations," said Christopher J. Calhoun, chief executive officer for Cytori. "We are preparing for the next steps in the process of working with the FDA to determine the specific device marketing application to submit, including whether clinical evaluations will be necessary."
Cytori explains that based on the jurisdictional determination from the FDA, marketing applications for the Celution(R) 700 device will be reviewed by the agency’s Center for Biologics Evaluation and Research. If clinical studies are required, they would be conducted in accordance with the Investigational Device Exemption (IDE) regulations, not the Investigational New Drug regulations applicable to drugs and biologics.
[Source: Original press release]